ES2929434T3 - Methods of bonding components to polymeric substrates - Google Patents

Abstract

Methods for bonding polymeric substrates to medical device component parts and assemblies including a tube and component part joined together using a solvent containing a tackifier. (Automatic translation with Google Translate, without legal value)

Description

DESCRIPTION

Methods of bonding components to polymeric substrates

related request

This application claims priority to US Provisional Patent Application No. 62/581,427, filed December 3, 2017.

technical field

The present disclosure relates generally to methods of bonding a component part to a polymeric substrate, such as medical tubing, and to medical device assemblies made from such methods.

Background

Various medical devices include a component part attached to a substrate. For example, medical tubes commonly include a component part attached thereto. Said component parts may include drainage members, connectors, gaskets, etc. In the field of urinary catheters, for example, the catheter tube (polymeric substrate) has a drainage member (component part) connected to the catheter tube.

In many cases, component parts are attached to substrates by overmolding or adhesives, such as UV-curable adhesives. While the use of overmolding or adhesives can provide adequate bonding or fixing, bonding by these mechanisms can often add time and expense to ^{the manufacturing process. For example, when using a UV curable adhesive , the adhesive is exposed to a} source of UV energy for a period of time. This requires the addition of a UV light curing box or system to the manufacturing line and adds additional time to the manufacturing process to provide the UV cure. Similarly, when overmolding is employed, an injection molding tool is typically required on the manufacturing line and additional time is required to cool the overmolding prior to further processing of the medical device.

Solvent bonding is a common and inexpensive method used to join compatible materials such as PVC, polystyrene, and polyurethanes. Solvents, such as cyclohexanone, are commonly used for solvent bonding. However, certain materials are not suitable for solvent bonding or do not form strong bonds. Such materials include, but are not limited to, thermoplastic olefins and thermoplastic elastomer block copolymers based on SEBS, SBS and SIS and blends of block copolymer elastomers with polyolefins, PEBAX, EVA and other polymer modifiers, see EP2407512.

US2015368419A1 describes a coated rubber composition including a rubber composition coated with a liquid cooling agent selected from the group consisting of one or more liquid terpenes, limonene, carvone, pinene, pine needle oil, citral, orange oil, aliphatic C9-C15, C9-C15 cycloaliphatics, ethyl lactate, dipentene, 1,8-cineole, eucalyptol, citronellol, geraniol, citronellene, terpinen-4-ol, and combinations thereof. JP2008201994A describes a tackifier composition comprising (a) a combination of one or more terpene-based compounds selected from a group consisting of monoterpenes and sesquiterpenes, and (b) at least one of terpene-based rubber components Unvulcanized diene dissolved or dispersed in component (a). CN106189041A discloses a solvent bonded, kink resistant transparent infusion tubing material which is composed of thermoplastic styrene elastomer, polypropylene random copolymer, adhesion promoter, antioxidant and lubricant.

Therefore, there continues to be a need for methods of bonding medical substrates to component parts.

Resume

There are various aspects of the present content that can be included separately or together in the devices and systems described and claimed below. These aspects can be used alone or in combination with other aspects of the content described herein, and the description of these aspects together is not intended to exclude the use of these aspects separately or the claim of said aspects separately or in different combinations. as set forth in the claims appended hereto.

The invention relates to a method for bonding a component part to a polymeric substrate according to claim 1.

The method can be applied to a medical tube assembly comprising a medical tube and a part component, wherein at least one of the medical tube and the component part is made of a block copolymer and wherein the component part and the tube are bonded together using a solvent-containing tackifier.

Detailed Description of the Illustrated Embodiments

The embodiments disclosed herein are for the purpose of providing a description of the present content, and it is understood that the content may be embodied in various other forms and combinations not shown in detail. Therefore, the specific embodiments and features disclosed herein are not to be construed as limiting the content, as defined by the appended claims.

The present application describes methods for bonding a component part to a polymeric substrate. The methods may include applying a solvent containing a tackifier to a surface of at least one of the polymeric substrate and the component part. The solvent swells or partially swells the materials to which it is applied, allowing some of the tackifier to penetrate the material. One of the polymeric substrate and the component part to which the solvent is applied may be made of a block copolymer that is compatible with the tackifier, so that the surface of one of the polymeric substrate and the component part becomes sensitive to pressure or similar to pressure sensitive after application of the solvent. In one embodiment, the material becomes pressure sensitive/pressure sensitive-like after application and drying of the solvent. The polymeric substrate and the component part are brought into contact with each other, thereby bonding the component part to the polymeric substrate.

In one embodiment, the polymeric substrate and/or the component part may be made of a thermoplastic elastomer (TPE) wherein the substrate and/or the component part may be made solely or predominantly of a TPE or the substrate and the component part may include a TPE. For example, the substrate and/or the component part can be made of TPE combined with other polymers. In one embodiment, the TPE may be compounded, for example, with a polyolefin such as polypropylene, polyethylene, polyamide block copolymer, polyurethane, polyester, EVA, and the like.

The TPE may be a block copolymer, such as a styrenic block copolymer TPE. Such styrenic block copolymer TPEs can include styrene-butadiene-styrene (SBS) or styrene-ethylenebutylene-styrene (SEBS). Said SEBS and SBS TPE materials are commonly, but not exclusively, sold under the trade name Kraton®. In one embodiment, the SEBS may have a styrene content greater than 20%. The styrene content can be higher or lower depending on the desired application. Furthermore, the substrate and/or component part may be made of SBS or SEBS combined with another polymer, such as a polyolefin (which may be, for example, polypropylene, polyethylene, polyamide block copolymer, polyurethane, polyester, and the like).

The solvent applied to the substrate and/or component part includes a resin tackifier/tackifier. As for the solvent, it may be strong enough to swell or partially swell the TPE material of the substrate and/or the component part. Although the solvent can also dissolve or partially dissolve the TPE material, it is not necessary to dissolve the TPE. Solvents can include, for example, cyclohexanone, toluene, methyl ethyl ketone, tetrahydrofuran, xylene, isopropanol alcohol, heptane, or mixtures thereof. In one embodiment, the solvent can be a mixture that includes cyclohexanone and methyl ethyl ketone. In another embodiment, the mixture can be toluene and methyl ethyl ketone. In each of these mixtures, the cyclohexanone or toluene may be in a ratio of approximately 2:1 to the methyl ethyl ketone. For example, the mixture may include a 70:30 ratio of cyclohexanone to methyl ethyl ketone or a 70:30 ratio of toluene to methyl ethyl ketone.

Returning to the tackifier, preferably, the tackifier is compatible with the midblock of the TPE block copolymer. For example, when the tPe is SBS or SEBS, the tackifier may be compatible with the midblock of these copolymers. In one embodiment, the tackifier may be hydrogenated wood rosin (such as Foral 105E supplied by Eastman), a phenolic terpene such as Sylvarez TP105 (Arizona Chemical), or a C5 or C9 hydrocarbon-based resin or combinations thereof.

In addition, the solvent can also include other additives, such as an amount of SEBS or SBS.

In one embodiment, the tackifier-containing solvent can include from about 92% by weight to about 98% by weight solvent and from about 2% by weight to about 8% by weight tackifier. In one embodiment, the tackifier may be less than about 20% by weight or 8% by weight or 6% by weight of the tackifier-containing solvent. For example, the tackifier-containing solvent may include about 95% by weight of the solvent and about 5% by weight of the tackifier. The solvent can be, for example, a cyclohexanone/methyl ethyl ketone mixture in a ratio by weight of 70:30 and the tackifier may be hydrogenated wood rosin. In another example, the tackifier-containing solvent may include about 92% by weight solvent, about 4% by weight of a tackifier, and about 4% by weight of an additive. The solvent can be, for example, a mixture of toluene/methyl ethyl ketone in a weight ratio of 70:30, the tackifier can be hydrogenated wood resin and the additive can be SEBS or SBS.

In one embodiment of a method for attaching a drainage member to a catheter tube, the drainage member and/or catheter tube may be made of a TPE, such as any of the TPEs described above. A solvent containing a tackifier, such as any of those described above, is applied to the outer surface of the catheter and/or the inner surface of the drainage member. The solvent containing tackifier may be applied by dip coating, spraying, brushing or any other suitable application process. Next, the catheter tube is brought into contact with the drainage member, so that the surface(s) to which the solvent containing a tackifier was applied is brought into contact with another surface for bonding. The surfaces. For example, the catheter tube can be inserted into one end of the drainage member so that the surface of the outer surface of the catheter tube contacts the inner surface of the drainage member. The surface of the catheter tube abuts that of the drainage member, thereby adjoining the drainage member to the catheter tube. Because this bonding occurs relatively quickly, the catheter tube can undergo further processing in the manufacturing process. In one embodiment, the bond can be formed in about 60 seconds or less. Thus, the catheter tubes having the drainage member attached thereto can be relatively quickly subject to coating application, such as hydrophilic coating, packaging, and radiation sterilization. Radiation sterilization can be, for example, gamma or electron beam radiation at a dose between about 25 kGy and 45 kGy. In addition, when the catheter includes a hydrophilic coating, the catheter can be packed in contact with a wetting fluid.

Thus, the methods can be employed to produce a medical tubing assembly comprising a medical tubing and a component part, wherein at least one of the medical tubing and the component part is made of a block copolymer, and wherein the component part and the tube are bonded together using a solvent containing a tackifier.

The catheter and drainage members joined by the above methods can have a bonding force greater than about 40 N. For example, the bonding force can be greater than 70 N or greater than 80 N. Surprisingly, it was found that the force bonding is improved after the bonded materials have been exposed to radiation. For example, binding strength may improve after receiving a dose between about 25 kGy and 45 kGy of gamma or electron beam radiation. In one embodiment, binding is increased after electron beam or gamma irradiation sterilization. Bonding forces can be measured using a tensile tester with the drain member and tubes clamped 5 cm apart and pulled at 10mm/sec until break.

It will be understood that the embodiments described above are illustrative of some of the applications of the principles of the present content. Numerous modifications can be made by those skilled in the art without departing from the scope of the claimed content, including those combinations of features that are individually disclosed or claimed herein. For these reasons, the scope of the present document is not limited to the above description, but is as set forth in the following claims, and it is understood that the claims may be directed to the features of the present document, including as combinations of features that are individually disclosed or claimed herein.

Claims (13)

1. A method of bonding a component part to a polymeric substrate, the method comprising: applying a solvent containing a tackifier to a surface of at least one of a polymeric substrate and a component part, the one of the polymeric substrate and the component part to which the solvent is applied being made of a styrenic block copolymer blend and a second polymer comprising a polyolefin, the tackifier comprising a hydrogenated rosin, an ester of hydrogenated rosin, phenolic terpene, C5 or C9 hydrocarbon resin; contacting the polymeric substrate with the component part to form a bond between them; Y exposing the polymeric substrate and attached component part to radiation. The method of claim 1, wherein the polymeric substrate comprises a catheter tube and the component part comprises a drainage member. The method of any one of claims 1 and 2, wherein the block copolymer is a thermoplastic elastomer. The method of any one of claims 1-3, wherein the styrenic block copolymer comprises styrene ethylene butylene styrene or styrene butylene styrene polymer. The method of claim 4, wherein the styrene content is greater than 20 percent by weight. The method of any one of claims 1-5, wherein the polyolefin comprises polypropylene. The method of any one of claims 1-6, wherein the solvent swells the styrenic block copolymer. The method of any one of claims 1-7, wherein the solvent comprises one or more of cyclohexanone, toluene, methyl ethyl ketone, xylene, isopropanol, and tetrahydrofuran. The method of any one of claims 1-8, wherein the tackifier is compatible with a midblock of the styrenic block copolymer. The method of any one of claims 1-9, wherein the tackifier is in an amount of less than 20% by weight of the tackifier-containing solvent. The method of any one of claims 1-10, wherein the tackifier-containing solvent is applied to the surface of the polymeric substrate. The method of any one of claims 1-11, wherein the tackifier-containing solvent is applied to the surface of the component part. The method of any one of claims 1-12, wherein the tackifier-containing solvent further includes SEBS or SBS.